Quality Assurance Manager GMP/GDP (m/f/d)

Ihre Aufgaben:
• Provide Quality oversight of external GDP operations, e.g. lead QMS activities, including Complaints, Deviations, Change Control, Audits, Self-Inspections, and Training
• Ensure GxP partners (i.e. CMOs, Distributors, etc.) are compliant for regulatory inspections and monitor progress during inspections
• Support Batch Record review, release preparation and batch disposition of APIs, bulk drug product, and finished products manufactured by contract manufacturers
• Monitor performance metrics, provide regular updates to management on assigned project progress, and escalate challenges as needed
• Execute and support external and internal audits (GDP/GMP)
• Support Health Authority inspection and customer audits preparation and management
• Perform other tasks as assigned in accordance with SOPs, regulatory agencies, and GxP-Guidelines

Ihre Qualifikationen:
• Bachelor’s degree in science or a combination of education and equivalent work experience
• Pharmaceutical or biotechnology industry experience
• Experience in Quality Supplier Management
• Excellent knowledge in GMP and GDP regulations
• Worked in an area with commercial QA experience as an asset
• Experience with electronic Document Management Systems, Quality Management Systems, Serialization and Traceability Solutions

Ihre Vorteile:
• Interesting working environment
• Support during the recruitment process by us

Projektdauer: 12 MM+





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